Article Impact Level: HIGH Data Quality: STRONG Summary of The Lancet, S0140673624027557. https://doi.org/10.1016/S0140-6736(24)02755-7 Dr. Giulia Argentesi et al.
Points
- This research assessed the efficacy of endoscopic ultrasound-guided trans-gastric radiofrequency ablation (EUS-RFA) as a non-invasive approach for treating left-sided aldosterone-producing adrenal adenomas (APAs), frequently associated with hypertension.
- A total of 35 ablation procedures were conducted on 28 participants (75% male, average age 57.7 years) from 2018 to 2023. The technique employed a 19G ablation catheter with continuous ultrasound guidance, demonstrating no notable safety concerns.
- In terms of biochemical and clinical results, 75% of patients achieved a complete or partial biochemical cure, indicated by a lower aldosterone-to-renin ratio. Additionally, 43% experienced a clinical resolution of hypertension, marked by reduced blood pressure levels.
- Molecular Imaging Insights: PET-CT scans indicated decreased radiotracer uptake in treated APAs, with four patients experiencing complete resolution of hypertension without the need for antihypertensive therapy.
- The results indicate that EUS-RFA presents a promising alternative to adrenalectomy. This paves the way for a clinical trial aimed at comparing thermal ablation with surgical approaches to assess long-term advantages in the management of APA.
Summary
This study assessed the practicality of endoscopic ultrasound-guided trans-gastric radiofrequency ablation (EUS-RFA) as a non-invasive approach for treating left-sided aldosterone-producing adrenal adenomas (APAs), frequently associated with hypertension. A total of 28 participants (75% male, average age 57.7 years) diagnosed with primary aldosteronism according to Endocrine Society criteria were involved in the study, which included 35 ablation procedures conducted from February 2018 to February 2023. The main focus was on safety, with no predetermined significant risks, like gastric or adrenal puncture, noted in any patient. Subjects received molecular imaging for the diagnosis and localization of the APA, subsequently undergoing EUS-RFA with a 19G ablation catheter, all performed under continuous ultrasound guidance.
Secondary endpoints involved assessing variations in radiotracer uptake of the ablated APA in comparison to the contralateral adrenal at the 3-month mark. A localized reduction in radiotracer uptake was noted in all PET-CT-positive APAs, with 75% (95% CI 55–91) of patients experiencing a complete or partial biochemical cure, indicated by decreases in plasma aldosterone to renin ratio. Furthermore, 43% (24–61) of participants achieved a clinical resolution of hypertension, characterized by a decrease in blood pressure levels. In four patients, the total resolution of the APA on molecular imaging correlated with normalized blood pressure (systolic <135 mmHg and diastolic <85 mmHg) without the use of antihypertensive therapy.
The findings suggest that EUS-RFA presents a viable and secure option compared to total adrenalectomy for left-sided APAs, offering the possibility of curing primary aldosteronism and hypertension. This research has guided the development of a crucial trial that will compare thermal ablation with surgical methods, focusing on the long-term advantages of this less invasive technique for individuals with APAs.
Link to the article: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02755-7/fulltext
References Argentesi, G., Wu, X., Ney, A., Goodchild, E., Laycock, K., Lee, Y.-N., Senanayake, R., MacFarlane, J., Ng, E., Kearney, J., O’Toole, S., Salsbury, J., Carroll, N., Gillett, D., Tadross, J. A., Marker, A., Godfrey, E. M., Goodchild, G., Bestwick, J. P., … Wilson, P. (2025). Endoscopic, ultrasound-guided, radiofrequency ablation of aldosterone-producing adenomas (Fabulas): A UK, multicentre, prospective, proof-of-concept trial. The Lancet, S0140673624027557. https://doi.org/10.1016/S0140-6736(24)02755-7